[Federal Register Volume 85, Number 173 (Friday, September 4, 2020)]
[Rules and Regulations]
[Pages 55193-55196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17791]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0273; FRL-10012-18]


Pydiflumetofen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the inadvertent 
residues of pydiflumetofen in or on animal feed, nongrass, group 18, 
hay; grass, forage, fodder and hay, group 17, except straw; and grass, 
forage, fodder and hay, group 17, straw. Syngenta Crop Protection, LLC 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective September 4, 2020. Objections and 
requests for hearings must be received on or before November 3, 2020, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2019-0273, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2019-0273 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
November 3, 2020. Addresses for mail and hand delivery of objections 
and

[[Page 55194]]

hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2019-0273, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 7, 2019 (84 FR 26630) (FRL-9993-
93), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9F8744) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, 
NC 27419. The petition requested that 40 CFR 180.699 be amended by 
establishing tolerances for inadvertent residues of the fungicide, 
pydiflumetofen (3-(difluoromethyl)-N-methoxy-1-methyl-N-[1-methyl-2-
(2,4,6 trichlorophenyl)ethyl]-1H-pyrazole-4-carboxamide) in or on rice, 
grain at 0.01 parts per million (ppm); non-grass animal feed (Crop 
Group 18), forage at 0.01 ppm; non-grass animal feed (Crop Group 18), 
hay at 0.03 ppm; grasses, forage at 0.15 ppm; grasses, hay at 0.50 ppm; 
grasses, straw at 0.04 ppm. That document referenced a summary of the 
petition prepared by Syngenta Crop Protection, LLC, the registrant, 
which is available in the docket, http://www.regulations.gov. There 
were no comments received in response to the notice of filing. Based 
upon review of the data supporting the petition, EPA is establishing 
tolerances that vary slightly from what the petitioner requested, by 
using altered commodity definitions to reflect the Agency's preferred 
terminology and adjusted tolerance levels for several commodities. In 
addition, EPA is not establishing tolerances for residues of 
pydiflumetofen in or on rice, grain and non-grass animal feed (crop 
group 18), forage. The reasons for these changes are explained in Unit 
IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for pydiflumetofen including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with pydiflumetofen 
follows.
    On August 12, 2019, EPA published in the Federal Register a final 
rule establishing a tolerance for residues of the fungicide 
pydiflumetofen in or on various commodities. See (84 FR 39761) (FRL-
9997-09). EPA is incorporating by reference the aspects of that 
rulemaking that remain the same for this rulemaking: The toxicological 
profile and points of departure/levels of concern; the determination 
for reducing the children's safety factor and conclusions about 
cumulative risk. The Agency conducted an updated risk assessment to 
evaluate exposure to residues of pydiflumetofen from the reduced plant-
back intervals on rice, grass grown for seed, non-grass animal feed 
crop group 18, and tobacco and concluded that the new use patterns 
would not impact previously assessed drinking water, dietary (food and 
drinking water), or residential, exposures to humans from the reduced 
plant-back intervals. Therefore, the Agency's conclusions of aggregate 
risk remain unchanged from the August 12, 2019 rulemaking and are also 
incorporated into this rulemaking.
    Further information about EPA's risk assessment and determination 
of safety supporting the tolerances for inadvertent residues 
established in the August 12, 2019 Federal Register action, as well as 
the new pydiflumetofen tolerance can be found at http://www.regulations.gov in the document entitled, ``Pydiflumetofen. Human 
Health Risk Assessment for New Foliar Uses on Berries, Low Growing, 
Crop Subgroup 13-07G; Brassica Head and Stem Crop Group 5-16; Brassica 
Leafy Greens Subgroup 4-16B; Bulb Vegetable Crop Subgroup 3-07A; Green 
Onion Crop Subgroup 3-07B; Bushberry Crop Subgroup 13-07B; Citrus Fruit 
Crop Group 10-10; Cottonseed Subgroup 20C; Edible-podded Legume 
Vegetables Subgroup 6A; Succulent Shelled Pea and Bean Subgroup 6B; 
Pome Fruit Crop Group 11-10; Root Vegetable Crop Subgroup 1A; Sorghum; 
Stone Fruit Crop Subgroups 12-12A, 12-12B, and 12-12C; Sunflower 
Subgroup 20B; Tree Nut Crop Group 14-12; Leaves of Root and Tuber 
Vegetable Crop Group 2; and New Seed Treatment Uses on Rapeseed Crop 
Subgroup 20A and Soybean; and Registration of a New Seed Treatment End-
Use Product,'' dated July 22, 2019, in docket ID EPA-HQ-OPP-2018-0688.
    Therefore, based on the risk assessments and information described 
above, EPA concludes there is a reasonable certainty that no harm will 
result to the general population, or to infants and children, from 
aggregate exposure to pydiflumetofen residues. More detailed 
information on the subject action to establish tolerances in or on 
animal feed, nongrass, group 18, hay; grass, forage, fodder and hay, 
group 17, except straw; and grass, forage, fodder and hay, group 17, 
straw can be found in the document entitled, ``Pydiflumetofen. Human 
Health Risk Assessment for Amended Registrations to Allow 30-Day 
Minimum Plant-Back Interval (PBI) Restrictions for Rice, Grass Grown 
for Seed, Non-Grass Animal Feed Crop Group 18, and Tobacco and Petition 
for Inadvertent Tolerances in or on These Crops/Commodities.'' at 
http://

[[Page 55195]]

www.regulations.gov, under docket ID number EPA-HQ-OPP-2019-0273.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A multi-residue analytical method named Quick, Easy, Cheap, 
Effective, Rugged, and Safe (QuEChERS) is adequate as the enforcement 
method for plant commodities. QuEChERS as described in Eurofins 
validation study S14-05402. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email 
address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established MRLs for pydiflumetofen in or on any 
of the commodities under consideration.

C. Revisions to Petitioned-For Tolerances

    The requested tolerance for ``non-grass animal feed (Crop Group 
18), hay'' was modified to read ``Animal feed, nongrass, group 18, 
hay'' to be consistent with Agency naming practices. Requested 
tolerances for ``grasses, forage,'' ``grasses, hay,'' and ``grasses, 
straw'' were revised to read ``Grass, forage, fodder and hay, group 17, 
except straw'' and ``Grass, forage, fodder and hay, group 17, straw'' 
respectively, to be more consistent with the Agency's preferred 
vocabulary and because EPA considers group 17 to be inclusive of a 
general request for tolerances on grasses.
    Tolerances for inadvertent residues of pydiflumetofen were 
requested for non-grass animal feed (Crop Group 18), forage and rice, 
grain; however, the Agency is not setting tolerances because residues 
of pyflumetofen in field accumulation in rotational crop trials were 
found at <0.01 ppm in or on these commodities, and the Agency does not 
believe that tolerances are needed, in accordance with the Agency's 
guidance (OPPTS Guideline 860.1900).
    The Agency is setting a tolerance in or on animal feed, nongrass, 
group 18, hay, of 0.04 ppm rather than at 0.03 ppm as requested based 
on clover hay data. The Agency is also setting a tolerance in or on 
grass, forage, fodder and hay, group 17, except straw of 0.7 ppm based 
on available data, which indicates that residues in or on grass forage 
and hay are within 5x, but residues on straw are much lower.

V. Conclusion

    Therefore, tolerances are established for residues of 
pydiflumetofen in or on animal feed, nongrass, group 18, hay; grass, 
forage, fodder and hay, group 17, except straw; and grass, forage, 
fodder and hay, group 17, straw.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance for 
inadvertent residues in this final rule, do not require the issuance of 
a proposed rule, the requirements of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal Governments, on the relationship between the National Government 
and the States or Tribal Governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


[[Page 55196]]


    Dated: July 29, 2020.
Catherine Aubee,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA amends 40 
CFR chapter I as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.699, revise paragraph (d) to read as follows:


Sec.  180.699  Pydiflumetofen; tolerances for residues.

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for residues of pydiflumetofen, including its metabolites and 
degradates, in or on the commodities in table 2 to this paragraph (d). 
Compliance with the tolerance levels specified in table 2 to this 
paragraph (d) is to be determined by measuring only pydiflumetofen (3-
(difluoromethyl)-N-methoxy-1-methyl-N-[1-methyl-2-(2,4,6-
trichlorophenyl)ethyl]-1H-pyrazole-4-carboxamide) in or on the 
commodity:

                        Table 2 to Paragraph (d)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
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Animal feed, nongrass, group 18, hay....................            0.04
Grass, forage, fodder and hay, group 17, except straw...             0.7
Grass, forage, fodder and hay, group 17, straw..........            0.04
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[FR Doc. 2020-17791 Filed 9-3-20; 8:45 am]
BILLING CODE 6560-50-P


